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Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285010
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: placebo Drug: Pregabalin Phase 4

Detailed Description:
The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine
Study Start Date : November 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Drug: placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Active Comparator: Pregabalin
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Drug: Pregabalin

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Other Name: Lyrica




Primary Outcome Measures :
  1. Post Operative Morphine Consumption [ Time Frame: 6, 12, and 24 hours after operation ]
    Cumulative morphine consumption in the first 24 hours is recorded from IV PCA


Secondary Outcome Measures :
  1. Time to First Analgesia [ Time Frame: 24 hours ]
    Time to first analgesia is recorded from IV PCA.

  2. Pain Scores on the Visual Analog Scale [ Time Frame: 24 hours ]

    Pain score is evaluated by nurses using Numerical Rating Scale (NRS)

    Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome


  3. Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
    Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire

  4. Number of Patients Evaluating Their Satisfaction [ Time Frame: 24 hours ]
    Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
  2. Patient can use patient-controlled analgesia (IV PCA)

Exclusion Criteria:

  1. History of drug allergy to gabapentinoid and related drug
  2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
  3. Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285010


Locations
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Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Taniga Kiatchai, MD Mahidol University

Publications:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02285010    
Other Study ID Numbers: Si594/2014
First Posted: November 6, 2014    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019
Last Verified: November 2018
Keywords provided by Mahidol University:
pregabalin
postoperative pain
abdominal hysterectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Morphine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs